FDA Inefficiency Costs ‘Thousands of Lives and Billions of Dollars’ in Healthcare – Book

ObamaCare is still one of the biggest financial headaches suffered by businesspeople. But there’s more bad news for business.

Now, a book indicts the Food and Drug Administration (FDA) for massive problems that annually lead to the deaths of nearly a quarter of a million Americans and cost an unnecessary $200 billion+ in healthcare expenses.

The book is entitled, “AMERICAN GUINEA PIG: Everything That’s Wrong with the FDA and How to Avoid Becoming One of Its Victims.” Author Terence Mix is a noted Santa Barbara, Calif. attorney.

3D-Book-Cover-310x491“Every year about 230,000 Americans die as a result of an adverse reaction to one or more prescription and nonprescription drugs,” he writes.” In five years they kill in excess of one million Americans.”

Mr. Mix adds it is America’s third-leading cause of death, “behind only heart disease and cancer.”

Another ominous statistic, “…almost half – 105,000 – are taking the drug exactly as specified by the pharmaceutical company that manufactured the drug,” he writes.

“It has been calculated that the total annual health care costs as a consequence of adverse drug reactions equals $177.4 billion,” he asserts. “And that was in 2000 prices. The current number easily exceeds a staggering $200 billion.”

FDA shortcomings

His book spells out numerous problems with the FDA’s testing procedures and its drug-monitoring system. The author provides precautions and answers to solve the problems.

Incredibly, Mr. Mix indicates the FDA doesn’t even have criteria for safety precautions and what protections are needed.

“In fact, it’s a conclusion that was reached by the United States Government Accountability Office (GAO) in March 2006 following a 16-month investigation requested by Congress,” he explains.

“Most people seem to think that it is the FDA that either tests or directly oversees the testing of drugs,” says Mr. Mix.

“But unfortunately that is not the case,” he writes. “It is the drug company that designs the study, hand-picks the doctors participating in it, gathers the records, compiles the data and then spoon-feeds everything to the FDA, including its conclusions about the results.”

He uses a metaphor to describe problem.

“Along with the fox-guarding-the-henhouse problem,” he adds, “the current method of testing drugs is infested with multiple conflicts of interest – and that extends even into the FDA.”


“The drug industry and its regulator are joined at the hip,” he says, “and the top brass at the FDA view their association more as a partnership. This is why there is so much foot-dragging when it comes to removing a drug from the market or adding a stronger warning.”

Case studies

Mr. Mix’s book includes 10 drug case studies from ibuprofen to Cylert.

He says ibuprofen can be dangerous especially if taken with aspirin. He points out Cylert was finally banned in America in 2005 – six years after Canada outlawed it and eight years after Great Britain removed it from the shelves.

The author says he had two objectives in writing his book.

“One of the goals of the book,” explains Mr. Mix, “is to wake up Congress and point to changes in the law that could save 100,000 lives and cut $100 billion in healthcare costs. And that’s every year,” he adds.

Secondly, Mr. Mix says he wants consumers to get the information they need to avoid becoming victims. Indeed, the book lists the essential questions a patient should ask of the doctor and pharmacist.

You can visit the book’s Web site here.

My question is why are we paying for this debacle?

From the Coach’s Corner, I recommend two other books:

Must Read: ‘The Book…on Business from A to Z’A business book makes a bold promise. It’s entitled, “The Book…on Business from A to Z: The 260 Most Important Answers You Need to Know.” Is this an accurate title? Yes. It’s an authoritative book. 

A Book That Will Improve Your Life, Business and Community — Lovers of knowledge and wisdom periodically get an opportunity to read a book that delivers particularly valuable insights. Such a well-written book is “The Power of Habit: Why We Do What We Do in Life and Business,” by Charles Duhigg, who is also a reporter for The New York Times.

“The road to perdition has ever been accompanied by lip service to an ideal.”

-Albert Einstein


Author Terry Corbell has written innumerable online business-enhancement articles, and is a business-performance consultant and profit professional. Click here to see his management services. For a complimentary chat about your business situation or to schedule him as a speaker, consultant or author, please contact Terry.

8 Tips to Stop Healthcare, Insurance Inefficiency and Fraud

Inefficiency and fraud in healthcare and insurance has generated a ton of headlines. So a discussion about inefficiency and fraud has to include all stakeholders. 
That means patients, doctors and insurance companies – all must get a square deal for the healthcare system to work.

Firstly, it appears doctors are experiencing unnecessary challenges.

The Supreme Court rulings on ObamaCare didn’t solve anything for doctors – the undesirable law continues to remain a challenge to doctors in multiple ways. This also means ramifications for you as a patient.

Doctors are stressed by decreasing reimbursements for patient care by insurance companies, Medicare and Medicaid.

ID-10033362 photostockTrue, some doctors, who have good instincts, are better than others. It’s not uncommon for a patient to be misdiagnosed only to get a differing diagnosis from a different doctor.

This underscores the need for diagnostic proof in order for them to get paid, and explains why some doctors order more expensive tests than others.

Then, there are the decisions by health insurance companies adversely affecting doctors – interfering in doctor-patient relationships by dictating care, fees and inflexible fraud regulations.

Doctors and hospitals must spend too much time and resources on paperwork. Insurance companies are only doing what they feel is best to stay in business.

It’s not uncommon for doctors to decline to treat Medicaid patients – affordability is an issue for 31 percent of doctors. They aren’t accepting patients insured by the federal-state insurance program, according to the publication, Health Affairs.

Doctors are turning new Medicare patients. They’re only paid 40 cents on the dollar.

How ObamaCare increases costs

You might recall that the Obama Administration and other proponents promised that more low-income patients will get healthcare. However, with 31 percent of doctors now declining Medicaid patients, such patients have to spend extra time and money to find a primary healthcare provider. 

ObamaCare means costs will continue to increase. Why? ObamaCare is mandating that insurance companies accept everyone – no matter what.

Many such patients will only purchase healthcare when they absolutely need it – not before. The IRS penalty for being uninsured is less costly than the cost of premiums.

Because patients will wait too long to buy coverage, Medicare, Medicaid and insurance companies will have to continue increasing premiums – translating into higher costs for healthcare and insurance.

But the healthcare problem will worsen:

ObamaCare’s $716 billion in cuts in Medicare payment to providers – doctors and hospitals – threaten their livelihoods. Their only hope is for an increase in Medicaid patients. However, many states have already announced they will not participate in the expansion of Medicaid.

Fraud prevention

At first glance, one good provision in ObamaCare is an increased emphasis on prevention of Medicare and Medicaid fraud.

Published reports indicate Medicare fraud is in excess of $60 billion. The fraud is largely perpetrated by supply houses and furtive brokers.

For instance in 2011, the nation’s fraud-detection system cost $77 million. There’s also new fraud-command center costing $3.6 million, which doesn’t include the expense of fraud investigators across the U.S.

The fraud enforcement system has its detractors. Over the last six months of 2011, the system only prevented one check, in the amount of $7,591, from being paid to con artists.

So Senators Orrin Hatch (R-UT) and Tom Coburn (R-OK) wrote a letter to Dept. of Human and Health Services Secretary Kathleen Sebelius. They asked her to stop spending money on the system until it can become efficient. Their concerns were ignored.

Eight tips to prevent fraud

Fraud affects all of us – patients, doctors, taxpayers and the federal government.

The Federal Bureau of Investigation recommends these fraud-prevention tips:

1. Never sign blank insurance claim forms.

2. Never give blanket authorization to a medical provider to bill for services rendered.

3. Ask your medical providers what they will charge and what you will be expected to pay out-of-pocket.

4. Carefully review your insurer’s Explanation of Benefits (EOB) statement. Make sure you actually received the treatments for which your insurance was charged, and question suspicious expenses.

5. Do not do business with sales people door-to-door or over the phone who tell you that services of medical equipment are free.

6. Give your insurance/Medicare identification only to those who have provided you with medical services.

7. Keep accurate records of all health care appointments.

8. Know if your physician ordered equipment for you.

From the Coach’s Corner, also see:

“There are three things in the world that deserve no mercy, hypocrisy, fraud, and tyranny.
-Frederick William Robertson


Author Terry Corbell has written innumerable online business-enhancement articles, and is a business-performance consultant and profit professional. Click here to see his management services. For a complimentary chat about your business situation or to schedule him as a speaker, consultant or author, please contact Terry. 

Photo courtesy of photostock at www.freedigitalphotos.net

SBA Web Chat: Tips on Healthcare Tax Credits


Aug. 4, 2010

If you need up-to-date information on healthcare for your small business, the Small Business Administration is holding a Web Chat. The SBA’s Web Chat will highlight small business health care, with a focus on how the Affordable Care Act will benefit small business owners through available tax-saving incentives.  

Participants can learn about the newest tax credits they can take advantage of, and additional tax provisions to be implemented during the next several years.  

John Tuzynski, chief of Employment Tax and Specialty Programs for the Small Business Self-Employed (SB/SE) Division at the Internal Revenue Service, will host the August web chat on “Healthcare and Small Business.” 

SBA’s Web chat series provides small business owners with an opportunity to discuss relevant business issues online with experts, industry leaders and successful entrepreneurs.  Chat participants will have direct, real-time access to the Web chats via questions they submit online in advance and during the live session, with instant answers. 

WHEN: August 12, 2010, 2010, 1 p.m. ET. Mr. Tuzynski will answer questions for one hour.      

HOW: Participants can join the live Web chat by going online to www.sba.gov, and clicking “Online Business Chat.”  Web chat participants may post questions before the August 12th chat by visiting http://web.sba.gov/livemeeting/Aug10/ and posting their questions online. 

To review archives of past Web chats, visit online at http://www.sba.gov/tools/monthlywebchat/index.html.

From the Coach’s Corner, however, please note these columns:

Healthcare Reform Increases Costs to Workers, Study

How Healthcare Law Would Affect Small Business

Oxymorons: ‘Healthcare Reform’ and ‘Public Servants’

Showdown in Massachusetts – Winning the Hearts of Voters


Regarding the special election in Massachusetts, Martha Coakley vs. Scott Brown, pundits can choose to disagree in their analysis. But my sense is much of the analysis following the election appears erroneous.

Not to oversimplify the Massachusetts election, yes, voters were unconvinced about Ms. Coakley. Because of her ties with the top Democrats, voters were just as frustrated with the White House and Congress over the top 10 issues:

  1. Their ineptness in the sluggish economy and weak policies about job creation
  2. Failure to use a bully pulpit to get banks to lend to business and homeowners
  3. Wall Street bailouts
  4. Inability to regulate Wall Street with qualified, objective professionals and to end the dubious financial schemes and vehicles
  5. Disingenuous schemes to promote unwanted healthcare changes
  6. Deficit spending
  7. Weariness about big-brother government interfering with their businesses and lives
  8. Government’s preoccupation with pie-in-the-sky fantasies about solving unemployment with green initiatives for the short term
  9. Refusal to utilize the abundant but untapped offshore oil opportunities, which will result in higher tax revenue and create jobs
  10. Failure to develop an effective policy for China and its undervaluing of its currency, which subsidizes its exports to the U.S.

Healthcare reform?

Because of the unfortunate preoccupation with healthcare over economic issues, let’s consider the healthcare debate as one of the salient issues. Opponents to the healthcare proposals condemned the proponents’ healthcare proposals because they view it as a healthcare effort. They do not view it as healthcare reform and do not see any financial benefit.

Yes, polls show most Americans are opposed to the Senate and House bills. They are alarmed at the aggregate cost, and they are alarmed at the methods used to pass the bills.  For them, many aspects of these bills are unhealthy.

The bottom-line for voters: Arrogance of public officials and their denial of economic and political liberties to voters are the core issues.

Most voters are appalled by the arrogance of the healthcare proponents. The voters believe the priority should be listening to the American public and solving the economic issues.

Hopefully, the White House will learn what the Clinton Administration folks learned the hard way. It was David Gergen who saved the Clinton Administration when it was mired in chaos in 1993 following its failed healthcare initiative and stagnation from organizational failures. And America did not want a co-president. Mr. Gergen knew the Clinton White House needed to reboot to get on track – to deal with the preferred business of the voters.

That’s what the Obama White House needs to do. Stop the arrogance. Act on the changes desired by most Americans.

The words of business philosopher Dr. Peter Drucker are applicable: “Arrogance is being proud of ignorance.”

A strong political campaign is almost synonymous with effective business marketing. For a candidate to win an election in this economic environment, it’s important to use classic business principles.

Therefore, six elements are required for success –

  1. Effectively listen – leave the ego behind.
  2. Convey a heavy dose of empathy for voters with an attitude of gratitude like a true public servant. Approach the campaign like a hungry job applicant.
  3. Take the high road at every turn like a successful diplomat and partner with the right centers of influence.
  4. Conduct a campaign analysis of strengths, weaknesses, opportunities and threats.
  5. Develop a strategic action plan.
  6. Execute the strategies in Blue Angels-like precision.

If these lessons are learned, America will get on track. Otherwise, voters will continue their disgust over the arrogance, and stolen economic and political liberties.

From the Coach’s Corner, here’s more on my views regarding healthcare: Oxymorons: ‘Healthcare Reform’ and ‘Public Servants’

Seattle business consultant Terry Corbell provides high-performance management services and strategies.